Tainted Supplement Recalls Prompt Call For Tighter Regulations – Letter
This article was originally published in The Tan Sheet
A research letter says that tainted supplements accounted for more than half of class I recalls from 2004-2012, and the researchers argue for stricter regulation. Industry points to a steep drop-off after 2010, and call for stronger enforcement of existing regulations.
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The HHS Office of the Inspector General finds a number of issues with supplement structure/function claims, and makes several recommendations to FDA to reduce illegal claims and weak substantiation.
FDA threatens to take "swift and strong" enforcement action without warning, including filing criminal charges, against manufacturers, suppliers and distributors of tainted supplements, according to a letter sent to industry Dec. 15.
FDA's final rule for dietary supplement good manufacturing practices completed its phase-in for the industry June 25, and the agency now prepares to conduct inspections of small firms, which have struggled the most to comply with the regulation